Vaginal Dilators as a Medical Device
The Milli vaginal dilator is an FDA-cleared medical device intended for controlled dilation of the vagina. When cleared, a medical device is granted an indication for use. This is the Milli vaginal dilator’s labeled indication for use:
- For an examination (by your doctor)
- In preparation for a surgical procedure (that requires vaginal penetration)
- To help relieve the symptoms of vaginismus (a condition that involves tightening of the vaginal muscles) and related painful sex.
The Milli vaginal dilator has not been designed or studied for safety and effectiveness when used for:
- Dilation of the neovagina after gender-affirming* surgery—vaginoplasty (male-to-female, MTF)
- Maintaining patency after vaginoplasty for vaginal hypoplasia (e.g., Mayer-Rokitansky-Kuster-Hauser syndrome)
- Treatment of vaginal stenosis due to scarring from pelvic surgery or radiation
If you require vaginal dilation for the above uses, it is not included in the Milli vaginal dilator labeling. This is considered an “off-label” use. Read more about Milli vaginal dilator risks, contraindications, warnings, and precautions here.
Here’s Why:
In the above circumstances, patients are asked to adhere to specific aftercare post-op protocols requiring strict, daily prolonged dilation to achieve the desired outcomes.1,2 These purposes may require different tools and protocols due to the forces necessary for daily prolonged dilation. The daily vaginal dilation protocols and necessary forces may exceed the Milli device design specifications; this can lead to breakage of the device and potential injury to the vaginal tissue.
If you require a vaginal dilator for daily prolonged dilation, please collaborate with your healthcare provider to explore alternative vaginal dilator options and suitable treatment plans tailored to your situation.
At Materna Medical, we firmly believe that all individuals, Milli user or not, need access to accurate and safe medical information. We appreciate the emphasis on seeking alternative vaginal dilator options and appropriate protocols from healthcare providers for these situations. We always prioritize patient safety and following guidance from healthcare professionals. Please consult your healthcare professional to ensure the best approach for your needs and desired outcomes.
*Previously known as gender-reassignment surgery (GRS), sex-reassignment surgery (SRS), or gender-confirmation surgery (GCS).
Sources:
1. Callens N, De Cuypere G, De Sutter P, Monstrey S, Weyers S, Hoebeke P, Cools M. An update on surgical and non-surgical treatments for vaginal hypoplasia. Hum Reprod Update. 2014 Sep-Oct;20(5):775-801. doi: 10.1093/humupd/dmu024.
2. Massie JP, Morrison SD, Van Maasdam J, Satterwhite T. Predictors of Patient Satisfaction and Postoperative Complications in Penile Inversion Vaginoplasty. Plast Reconstr Surg. 2018 Jun;141(6):911e-921e. doi: 10.1097/PRS.0000000000004427.
